Chinese Herbal Medicine for Dialysis-related Myofascial Pain: Study Protocol for A Pilot Randomized Study

Phase 2

• Conditions: Myofascial Pain Syndrome
• Interventions: Drug: Chinese Herb

• Registration Number: NCT04417101
• Lead Sponsor: Chang Gung Memorial Hospital

Brief Summary

Dialysis-related myofascial pain in hemodialysis (HD) patients is an important issue that is associated with many other psychosomatic problems. Effective interventions are required to alleviate pain problems in this group. Chinese herbal medicine (CHM) has been tried as a potential therapeutic method to improve pain. The aim of this study is to evaluate the effect of a CHM formula intervention on pain intensity, daily function, and quality of life, and safety among HD patients in dialysis center within a southern Taiwan context.

Detailed Description

Not available

Study Timeline

• Status Verified: 2020-05
• Study First Submitted: 2020-05-27
• Study First Submitted QC: 2020-06-02
• Last Update Submitted: 2020-06-02
• Study First Posted: 2020-06-04
• Last Update Posted: 2020-06-04
• Study Start: 2020-07-01
• Primary Completion: 2021-06-30
• Study Completion: 2021-06-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• Adults (aged ≥ 20 y) undergoing conventional HD three times a week via an AV fistula;
• To have myofascial trigger points (MTrPs) in one or more of the following muscles around the AV fistula: the flexor carpi radialis, palmaris longus, the pronator teres, the palmaris longus, and/or the finger flexor, diagnosed by dialysis-related myofascial pain, which must be experiencing pain during HD [M1];
• Onset of symptoms within 1 month before enrollment;
• Capable of giving adequate response to pain;
• Have an exquisite tenderness was found on palpation in the taut band with moderate intensity of pain at baseline (ie, a pain score > 3 on a numeric rating scale);
• Can commit to not change their medication and dialytic method during the 10 weeks of this study.

Exclusion Criteria

• Severe chronic or acute disease interfering with attendance for therapy;
• Have comorbid conditions such as rheumatoid arthritis, stroke, tumor, coagulopathy, chronic liver disease, radiculopathies of the upper limb, recent history of cervical/shoulder/arm surgery, or trauma;
• Have depression and/or presence of a psychiatric disorder;
• Have taken painkillers, muscle relaxant, and anti-inflammatory medications or used topical anesthetics in the past week;
• Have allergy to Chinese herbal product;
• Unable to understand or sign an informed consent form.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
JBT treatment	Chinese Herb	The participants will be instructed to take their Chinese herbal medicine formula (CHM), which named Juan Bi Tang, and take it as a dose of 3 g (per bag) each time, trice daily for 4 weeks.

Primary Outcome Measures

Name	Time	Method
Quality of life during dialysis	1 year	Kidney Disease Quality of Life 36-Item Short-Form Survey

Secondary Outcome Measures

Name	Time	Method
Muscle power	1 year	Gripping algometer
Motor function of upper limb	1 year	Fugl-Meyer Assessment for upper extremity
Pain score during dialysis	1 year	Visual Analogue Scale (0-100)